BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OKAY II

    MDR report key: 19009520 · Received March 31, 2024

    Report

    Report Number
    3007835716-2024-00109
    Event Type
    Injury
    Date Received
    March 31, 2024
    Date of Event
    June 25, 2021
    Manufacturer
    GOODMAN CO., LTD.
    Product Code
    DTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION FOUND NO ABNORMALITIES IN THE PRODUCT'S FUNCTIONALITY, SO THE DEFINITIVE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. NO ABNORMALITIES WERE FOUND IN THE MANUFACTURING RECORDS OF THE PRODUCT. IT IS CONSIDERED THAT THE REPORTED EVENT WAS CAUSED BY AIR GETTING INTO THE PRODUCT DURING OPERATION OF THE CONCOMITANT DEVICE DUE TO THE INSERTION SPEED OF THE DEVICE INSERTED INTO THE PRODUCT OR THE INFLUENCE OF THE EQUIPMENT CONNECTED TO THE SIDE PORT, BUT THE DETAILED CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    WHEN THE PRODUCT WAS USED TO DELIVER A CONCOMITANT DEVICE, AIR WAS DRAWN IN THE PRODUCT AND ENTERED THE PATIENT'S BODY. TEMPORARILY DISRUPTING THE ELECTROCARDIOGRAM, SO MEDICATION WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594989 OKAY II Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass DTL GOODMAN CO., LTD. YSS0E YA2009022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention